MAUDE Adverse Event Report: MEDTRONIC HEART VALVE DIVISION POSTERIOR ANNULOPLASTY BAND; RING, ANNULOPLASTY

Model Number	H607M
Medical Device Problem Codes	Occlusion Within Device (1423); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Mitral Valve Stenosis (1965); No Information (3190)
Date of Event	12/22/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Conclusion: without the return of the product, no definitive conclusion can be made regarding the clinical observation.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information that 2 years and 9 months post implant of this mitral posterior annuloplasty band, the band was explanted and replaced with a bioprosthetic valve.The reason for the explant was not reported. no additional adverse patient effects were reported.
Additional Manufacturer Narrative
Medtronic received additional information that 2 years and 9 months post implant of this mitral posterior annuloplasty band, the band was explanted and replaced with a bioprosthetic valve due to stenosis.No additional adverse patient effects were reported.  if information is provided in the future, a supplemental report will be issued.

• Brand Name: POSTERIOR ANNULOPLASTY BAND
• Common Device Name: RING, ANNULOPLASTY
• Manufacturer (Section D): MEDTRONIC HEART VALVE DIVISION; 1851 e deere ave; santa ana CA 92705
• MDR Report Key: 7282214
• Report Number: 2025587-2018-00417
• Device Sequence Number: 16173757
• Product Code: KRH
• UDI-Device Identifier: 00613994759177
• UDI-Public: 00613994759177
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• PMA/510(K) Number: K960356
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/28/2019
• Device Model Number: H607M
• Device Catalogue Number: H607M63
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/30/2018
• Supplement Date Received by Manufacturer: 02/21/2018
• Initial Report FDA Received Date: 02/20/2018
• Supplement Report FDA Received Date: 03/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 51 YR